Systems, devices, and methods for an analyte sensor

Abstract

A system for measurement of an analyte level including an analyte sensor having an in vivo portion in contact with the interstitial fluid of a user and an ex vivo portion. The sensor further includes at least one working electrode and a reference electrode located on the in vivo portion, and a first substrate. The at least one working electrode and reference electrode sense signals associated with a measured analyte level in the interstitial fluid of a user. Further, the ex vivo portion includes a plurality of electronic components mounted thereon, and at least one of the electronic components are configured to receive the generated signals associated with the measured analyte level. The electronic components are mounted to the ex vivo portion using photonic soldering.

1 . A system for measurement of an analyte level, comprising:
 an analyte sensor having an in vivo portion configured to be positioned in contact with an interstitial fluid of a user and an ex vivo portion, the analyte sensor having a first substrate;
 at least one working electrode located on the in vivo portion; 
 a reference electrode located on the in vivo portion; and 
 a plurality of electronic components mounted on the ex vivo portion; 
   wherein the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user, and at least one of the plurality of electronic components being configured to receive the generated signals associated with the analyte level.   
     
     
         2 . The system of  claim 1 , wherein the plurality of electronic components are further configured to transmit the signals associated with the analyte level to a remote device having a display screen. 
     
     
         3 . The system of  claim 2 , wherein the remote device includes a display device, a mobile phone, or a wrist-mounted device. 
     
     
         4 . The sensor of  claim 1 , wherein the electronic components are mounted to the ex vivo portion using photonic soldering. 
     
     
         5 . The system of  claim 1 , wherein the first substrate is a flexible monolithic unit. 
     
     
         6 . The system of  claim 1 , wherein the plurality of electronic components include one or more processors and a battery. 
     
     
         7 . The system of  claim 6 , wherein the battery includes a printed battery. 
     
     
         8 . The system of  claim 1 , wherein the at least one working electrode is configured to sense at least one of lactate, glucose, and ketone. 
     
     
         9 . The system of  claim 1 , wherein the analyte sensor further comprises a second substrate having at least one antenna. 
     
     
         10 . The system of  claim 1 , wherein the plurality of electronic components includes at least a Wi-Fi antenna, NFC antenna, Bluetooth antenna, BTLE antenna, or GPS antenna. 
     
     
         11 . The system of  claim 1 , wherein the first substrate is one of polyamide or polyethylene terephthalate. 
     
     
         12 . The system of  claim 1 , further comprising:
 a sensor control device housing the analyte sensor; and   an applicator for delivery of the analyte sensor including:
 a housing including a sensor carrier configured to secure the sensor control device within an interior of the applicator; and 
 an applicator cap removably coupled to the housing to seal the interior of the applicator. 
   
     
     
         13 . The system of  claim 1 , wherein the plurality of electronics are electrically coupled to the at least one working electrode and the reference electrode. 
     
     
         14 . The system of  claim 1 , wherein the ex vivo portion comprises a first layer. 
     
     
         15 . The system of  claim 14 , wherein the first layer comprises a gradient mix of materials. 
     
     
         16 . The system of  claim 15 , wherein the gradient mix of materials comprises fiberglass. 
     
     
         17 . The system of  claim 15 , wherein the gradient mix of materials comprises approximately 10% fiberglass and the in vivo portion comprises PET. 
     
     
         18 . The system of  claim 14 , wherein the ex vivo portion comprises a second layer. 
     
     
         19 . The system of  claim 18 , wherein each of the first layer and the second layer comprise a gradient mix of materials. 
     
     
         20 . A method of assembling a system for measurement of an analyte level, comprising:
 providing an analyte sensor having an in vivo portion configured to be positioned in contact with an interstitial fluid of a user and an ex vivo portion, the analyte sensor having:
 a first substrate, 
 at least one working electrode located on the in vivo portion, and 
 a reference electrode located on the in vivo portion, 
 wherein the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user; and 
   mounting a plurality of electronic components to the ex vivo portion, at least one of the plurality of electronic components being configured to receive the generated signals associated with the analyte level.   
     
     
         21 . The method of  claim 20 , wherein providing the analyte sensor includes printing the at least one working electrode and the reference electrode on the substrate. 
     
     
         22 . The method of  claim 20 , wherein the plurality of electronic components are further configured to transmit the signals associated with the analyte level to a remote device having a display screen. 
     
     
         23 . The method of  claim 22 , wherein the remote device is at least one of a hand-held analyte monitoring device, a mobile phone, or a wrist-mounted device. 
     
     
         24 . The method of  claim 20 , further comprising mounting the electronic components to the ex vivo portion using photonic soldering. 
     
     
         25 . The method of  claim 24 , further comprising masking a portion of the first substrate prior to photonic soldering. 
     
     
         26 . The method of  claim 18 , further comprising coating the first substrate with a reflective coating prior to photonic soldering. 
     
     
         27 . The method of  claim 24 , further comprising providing a vacuum to prevent the first substrate from warping during the photonic soldering process. 
     
     
         28 . The method of  claim 20 , wherein the first substrate is a flexible. 
     
     
         29 . The method of  claim 20 , wherein the plurality of electronic components comprise one or more processors and a battery. 
     
     
         30 . The method of  claim 29 , wherein the plurality of electronic components further comprise at least one antenna. 
     
     
         31 . The method of  claim 29 , further comprising a second substrate having at least one antenna. 
     
     
         32 . The method of  claim 31 , wherein the at least one antenna includes a Wi-Fi antenna, NFC antenna, Bluetooth antenna, BTLE antenna, or GPS antenna. 
     
     
         33 . The method of  claim 29 , wherein the battery includes a printed battery. 
     
     
         34 . The method of  claim 20 , wherein the first substrate is one of polyamide or polyethylene terephthalate. 
     
     
         35 . The method of  claim 20 , further comprising printing the at least one working electrode on a first surface of the analyte sensor and printing the reference electrode on a second surface of the analyte sensor. 
     
     
         36 . The method of  claim 35 , wherein the electronic components are mounted to the first surface using photonic soldering. 
     
     
         37 . The method of  claim 36 , wherein the plurality of electronic components are mounted on the first surface before printing the at least one working electrode and the reference electrode. 
     
     
         38 . The method of  claim 20 , further comprising sterilizing the analyte sensor. 
     
     
         39 . The method of  claim 38 , wherein sterilizing the analyte sensor comprises using radiation sterilization, heat treatment, electronic-beam sterilization, gamma sterilization, x-ray sterilization, ethylene oxide sterilization, autoclave steam sterilization, chlorine dioxide gas sterilization, or hydrogen peroxide sterilization. 
     
     
         40 . The method of  claim 38 , wherein the analyte sensor is sterilized before mounting the plurality of electronic components to the ex vivo portion. 
     
     
         41 . The method of  claim 38 , wherein the analyte sensor is sterilized after mounting the plurality of electronic components to the ex vivo portion. 
     
     
         42 . The method of  claim 20 , wherein the ex vivo portion comprises a first layer. 
     
     
         43 . The method of  claim 42 , wherein the first layer comprises a gradient mix of materials. 
     
     
         44 . The method of  claim 42 , wherein the mix of materials comprises fiberglass. 
     
     
         45 . The method of  claim 42  wherein the gradient mix of materials comprises approximately 10% fiberglass and the in vivo portion comprises PET. 
     
     
         46 . The method of  claim 42 , wherein the ex vivo portion comprises at least a second layer. 
     
     
         47 . The method of  claim 46 , wherein each of the first layer and the at least second layer comprise a gradient mix of materials. 
     
     
         48 . A system for measurement of an analyte level, comprising:
 an analyte sensor having an in vivo portion configured to be positioned in contact with an interstitial fluid of a user and an ex vivo portion, the analyte sensor having
 a flexible substrate; 
 a membrane configured to regulate analyte influx disposed on the in vivo portion; 
 at least one working electrode located on the in vivo portion; 
 a reference electrode located on the in vivo portion; and 
 a plurality of electronic components mounted on the ex vivo portion using photonic soldering, the plurality of electronic components comprising a processor, a battery, and an antenna; 
   a sensor control device housing the analyte sensor; and   an applicator for delivery of the analyte sensor including:
 a housing including a sensor carrier configured to secure the sensor control device within an interior of the applicator; and 
 an applicator cap removably coupled to the housing to seal the interior of the applicator; 
   wherein the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user, and the antenna being further configured to receive the generated signals associated with the sensed analyte level.